Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female

December 8, 2024 updated by: Aya Saeed Khalil Shazly, Cairo University
The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Few researchers have detected the effects of ultrasonic cavitation on insulin resistance in subjects with central obesity. However, there were many conflicts and no clear evidence in the literature concerning the superiority of cavitation on body contour adjustment. Consequently, this study aimed to investigate the effects of ultrasound cavitation, aerobic exercise and a low-calorie dietary program on insulin resistance and total plasma HOMA ir and body contouring in female with abdominal obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female subjects with central obesity.
  • Female participants aged between 25 to 40 years.
  • Body Mass Index (BMI) ranged from 30 to 35 kg/m2 as high BMI indicates more obesity and central obesity.
  • Waist circumference greater than 88 cm, indicative of abdominal obesity.
  • Diagnosed with insulin resistance (HOMA-IR > 2.9).
  • Sedentary lifestyle, defined as engaging in less than 150 minutes of moderate-intensity physical activity per week.
  • Willingness to provide informed consent and comply with study procedures.

Exclusion Criteria:

  • • Subjects diagnosed with DM (HbA1c more than 6.5%).

    • History of metabolic disorders such as type 1 diabetes or thyroid disorders.
    • Subjects with BMI less than 30 kg/m2.
    • Subjects diagnosed with heart disease, liver as well as kidney diseases.
    • Subjects who take oral contraceptives.
    • Subjects with gestational Diabetes.
    • Pregnant or breastfeeding women were excluded from the study.
    • Use of weight-loss medications or supplements within the past six months.
    • Previous surgical procedures for weight loss or body contouring.
    • Contraindications to ultrasound therapy (e.g., metal implants in the abdomen, active skin infections).
    • Participation in another clinical trial within the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
this group receive ultrasound cavitation on abdominal muscles
Device: Ultrasound cavitation
Ultrasound Fat Cavitation (USFC) is the method in handling obesity, especially in destroying fat and shaping a particular part of the body. As one of the non-surgical correction methods, USFC is preferred at decreasing the risk of complications due to obesity.
Other Names:
  • Ultrasound Fat Cavitation (USFC)
Active Comparator: Group B
received aerobic exercises and low caloric diet treatment.
Other: Exercise
The female will stand on the cushioned tread and grasp by her both hands the two arms of the treadmill. Treadmill will adjust to apply moderate intensity training. It was used for 30 minutes divided into five-minutes warming up, twenty-minutes active exercise and five-minutes cooling down and it was used twice a week for twelve weeks.
Other Names:
  • aerobic exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HOMA ir
Time Frame: "From enrollment to the end of treatment at 8 weeks"
This study will evaluate changes in HOMA-IR from baseline to assess improvements in insulin sensitivity because of the ultrasound cavitation intervention.
"From enrollment to the end of treatment at 8 weeks"

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin fold by caliper
Time Frame: "From enrollment to the end of treatment at 8 weeks"
The skinfold measurements will be taken using a Lange Skinfold Caliper, which provides accurate and reliable readings
"From enrollment to the end of treatment at 8 weeks"
Waist circumference (WC) by tape measurement
Time Frame: "From enrollment to the end of treatment at 8 weeks"
Waist circumference (WC) is an essential anthropometric measure used to evaluate abdominal obesity. It serves as an indicator of visceral fat, which is associated with a higher risk of metabolic disorders, including insulin resistance, type 2 diabetes, and cardiovascular diseases. By measuring waist circumference.
"From enrollment to the end of treatment at 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012/005421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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